Evaluation of Pharmacist Intervention for Individuals With Uncontrolled Type 2 Diabetes
NCT ID: NCT05442840
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
60 participants
INTERVENTIONAL
2022-07-04
2026-06-30
Brief Summary
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Detailed Description
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All participants who consented will then be randomized into a control group which will not receive pharmacist intervention during the study period, or the intervention group which will receive pharmacist/PharmD Intern led intervention which includes a medication review, optimizing medication treatment options and frequent follow up and diabetes education. The control group participants will be offered pharmacist intervention following the study period. All participants will be asked to complete a participant survey at the start and end of the study. All participants will also have standard care from their physicians and other healthcare team members as required which would be standard of practice. All participants would also be asked to repeat their blood work at the end of the study period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Control Arm
The participants in this arm will receive standard of care from their physician as they would have been doing previously. This still may involve blood work, referrals to other health providers (except pharmacist) and medication adjustments driven by the pharmacist.
No interventions assigned to this group
Pharmacist Intervention Arm
The participants in this arm will receive standard of care from their physician in addition to pharmacist intervention. The pharmacist or pharmD intern leads the diabetes care for the patient typically, conducting a medication review, recommending medication changes, frequent follow up and requesting blood work and providing referrals to other health care providers as needed,which is standard care
Behavioral and drugs already approved and available for diabetes management
Pharmacists will review the patients information and medical history as well as drug coverage to discuss preferred treatment options to manage diabetes based on recommendations from Diabetes Canada treatment guidelines; all drugs have been approved and are available on the market; pharmacists will offer frequent follow up and provide basic diabetes education to the patient at each follow up appointment
Interventions
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Behavioral and drugs already approved and available for diabetes management
Pharmacists will review the patients information and medical history as well as drug coverage to discuss preferred treatment options to manage diabetes based on recommendations from Diabetes Canada treatment guidelines; all drugs have been approved and are available on the market; pharmacists will offer frequent follow up and provide basic diabetes education to the patient at each follow up appointment
Eligibility Criteria
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Inclusion Criteria
* Adults (age 18 and older) with type 2 diabetes with HbA1C 10 % or above
* Patients whom have not had previous clinical pharmacist directed intervention
* Agree to participate in the study, including frequent follow up, blood glucose home monitoring as directed and repeat lab work
* Willing to consider medication adjustments as deemed appropriate
* Willing to review and sign the Research Participant Information and Informed Consent Form
Exclusion Criteria
* Patients with type 1 diabetes, pre-diabetes or gestational diabetes (or whom are pregnant)
* Patients whom have had recent or ongoing clinical pharmacist directed intervention or intensive health care professional monitoring and guidance
* Patients with HbA1C less than 10%
* Patients whom refuse medication adjustments
* Patients with severe renal impairment or receiving dialysis treatments
18 Years
ALL
No
Sponsors
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University of Manitoba
OTHER
Responsible Party
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Locations
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Portage Clinic
Portage la Prairie, Manitoba, Canada
Countries
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References
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APDS Diabetes Knowledge Questionnaire - Baker. (n.d.). Retrieved March 22, 2022, from https://www.baker.edu.au/-/media/documents/impact/ausdiab/questionnaires/ausdiab-diabetes-knowledge-questionnaire-2004.pdf?la=en
Schmitt A, Gahr A, Hermanns N, Kulzer B, Huber J, Haak T. The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control. Health Qual Life Outcomes. 2013 Aug 13;11:138. doi: 10.1186/1477-7525-11-138.
36-Item Short form survey instrument (SF-36). RAND Corporation. (n.d.). Retrieved March 21, 2022, from https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form/survey-instrument.html
Jacobson, A. M., & Diabetes Control & Complications Trial Research Group. (1994). The Diabetes Quality of Life Measure. In C. Bradley (Ed.), Handbook of psychology and diabetes: A guide to psychological measurement in diabetes research and practice (pp. 65-87). Harwood Academic Publishers/Gordon.
Bradley C: The Diabetes Treatment Satisfaction Questionnaire: DTSQ. In Handbook of Psychology and Diabetes: a guide to psychological measurement in diabetes research and practice. Edited by: Bradley C. Chur, Switzerland: Harwood Academic Publishers; 1994:111-132
Syarifuddin S, Nasution A, Dalimunthe A, Khairunnisa. Impact of Pharmacist Intervention on Improving the Quality of Life of Patients with Type 2 Diabetes Mellitus. Open Access Maced J Med Sci. 2019 Apr 29;7(8):1401-1405. doi: 10.3889/oamjms.2019.140. eCollection 2019 Apr 30.
Bukhsh A, Nawaz MS, Ahmed HS, Khan TM. A randomized controlled study to evaluate the effect of pharmacist-led educational intervention on glycemic control, self-care activities and disease knowledge among type 2 diabetes patients: A consort compliant study protocol. Medicine (Baltimore). 2018 Mar;97(12):e9847. doi: 10.1097/MD.0000000000009847.
Abdulrhim S, Awaisu A, Ibrahim MIM, Diab MI, Hussain MAM, Al Raey H, Ismail MT, Sankaralingam S. Impact of pharmacist-involved collaborative care on diabetes management in a primary healthcare setting using real-world data. Int J Clin Pharm. 2022 Feb;44(1):153-162. doi: 10.1007/s11096-021-01327-x. Epub 2021 Oct 12.
Stading, J., Herrmann, J., Walters, R., Destache, C., Chock, A. (2009). Impact of Pharmacist Intervention on Diabetes Patients in an Ambulatory Setting. Diabetes Spectrum, Volume 22, Number 4, (241-246). https://diabetesjournals.org/spectrum/article/22/4/241/2441/Impact-of-Pharmacist-Intervention-on-Diabetes
Jennings DL, Ragucci KR, Chumney EC, Wessell AM. Impact of clinical pharmacist intervention on diabetes related quality-of-life in an ambulatory care clinic. Pharm Pract (Granada). 2007 Oct;5(4):169-73. doi: 10.4321/s1886-36552007000400005.
Butt M, Mhd Ali A, Bakry MM, Mustafa N. Impact of a pharmacist led diabetes mellitus intervention on HbA1c, medication adherence and quality of life: A randomised controlled study. Saudi Pharm J. 2016 Jan;24(1):40-8. doi: 10.1016/j.jsps.2015.02.023. Epub 2015 Mar 6.
Shane-McWhorter L, McAdam-Marx C, Lenert L, Petersen M, Woolsey S, Coursey JM, Whittaker TC, Hyer C, LaMarche D, Carroll P, Chuy L. Pharmacist-provided diabetes management and education via a telemonitoring program. J Am Pharm Assoc (2003). 2015 Sep-Oct;55(5):516-26. doi: 10.1331/JAPhA.2015.14285.
Related Links
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Diabetes Canada (2022, March). Diabetes in Manitoba: Backgrounder. Ottawa: Diabetes Canada; 2021.
Canadian Pharmacists Association, (2022, March). More and more Canadians say pharmacists play essential role in Canada's health care system, 2017.
The Canadian Diabetes Association. (2018). Diabetes Canada Clinical Practice Guidelines. Resources for People with Diabetes, Managing my Diabetes - My Action Plan.
The Canadian Diabetes Association. (2015). Diabetes Canada Clinical Practice Guidelines. Patient resources, Medication sheet: SGLT2 Inhibitors
The Canadian Diabetes Association. (2018). Diabetes Canada Clinical Practice Guidelines. Quick Reference Guide.
The Canadian Diabetes Association. (2017). Tools and Resources, Insulin Prescription
The Canadian Diabetes Association. (2018). Diabetes Canada Clinical Practice Guidelines. Tools and Resources, Insulin pen start checklist
The Canadian Diabetes Association. (2018). Appendix 7: Therapeutic Considerations for Renal Impairment. (2018). Canadian Journal of Diabetes, 42
The Canadian Diabetes Association. (2020). 2020 Chapter Updates: Pharmacologic Glycemic Management of Type 2 Diabetes in Adults: 2020 Update
Health Canada. (April 2020). Side Effect Reporting Form
The Canadian Diabetes Association. (2018). Appendix 6: Types of insulin. (2018). Canadian Journal of Diabetes, 42
Other Identifiers
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HS25460 (B2022:031)
Identifier Type: -
Identifier Source: org_study_id
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